The Use of SmartPhone App (Kandoo) to Enhance Efficacy of Brief Behavioral Activation in Reducing Mood Disorder Symptoms

NCT06825637 | Not Yet Recruiting

• 1 other identifier: Pro00081465
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The current project is a pilot study that seeks to compare the efficacy of Brief Behavioral Activation's treatment-as-usual that uses paper and pencil tools to Kandoo, a digital, gamified version of activity scheduling and self-monitoring, in a diverse sample of youth presenting with clinically significant symptoms of depression. We will compare the level of pre- and post-treatment depressive symptoms in participants, who will participate in an 8-week brief behavioral activation treatment protocol augmented with Kandoo to the pre- and post- treatment depressive symptoms in the control participants, who will participate in 8-week, treatment as usual, brief behavioral activation treatment protocol. To explore treatment response for the clinically significant symptoms, we will obtain pre- and post-treatment measures of depression, global functioning, and patient goals. During the standard clinical intake, additional information will be obtained, including detailed demographics, medical history, mental health status, and social skills. Beyond determining the overall effectiveness of BBA augmented with Kandoo, the sample diversity and availability of clinical behavioral observations of the participants will permit the development of explanatory models of predictive factors for BBA with Kandoo intervention outcomes.

Conditions

Depression Disorders

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms and Global Functioning

  We will compare the pre- and post-treatment depressive symptoms and global functioning of participants, who completed BBA with Kandoo.

  8 weeks

Secondary Outcomes (1)

• Improvement Factors

  8 weeks

Study Arms (2)

Brief Behavioral Activation with Kandoo

EXPERIMENTAL

Participants will use Kandoo to track their activities while receiving Brief Behavioral Activation treatment.

Device: Kandoo

Brief Behavioral Activation with traditional paper pencil tracking

NO INTERVENTION

Participants will use paper and pencil worksheets to track their activities while receiving Brief Behavioral Activation treatment.

Interventions

Kandoo DEVICE

Kandoo is an app that allows patients to track their activities in an engaging and gamified platform.

Brief Behavioral Activation with Kandoo

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 13.0 to 25:11 years old
• Sex: male and female
• Currently enrolled as a patient in the CMI clinic or Fort Health Virtual Outpatient Mental Health Clinic
• Current clinical presentation must include symptoms of mild-to-moderate depression, two of which must be depressed/irritable mood most of the day and markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day
• Access to a smart device
• Internet connectivity
• Approval by parents and clinician for participants 13-17.11; approval by clinician for participants 18+

You may not qualify if:

• eating disorder
• manic episode (any current or history)
• psychotic episode or psychotic disorder
• active suicidality
• homicidal
• Any neurologic impairment that limits the ability to use a touch screen.

Sponsors & Collaborators

• Child Mind Institute: lead
• Fort Health: collaborator

Study Sites (1)

Child Mind Institute

New York, New York, 10022, United States

Location

Study Officials

• Michael Milham, MD, PhD

  Child Mind Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Alexander

CONTACT

646-625-4383; lindsay.alexander@childmind.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)